Description and Brand Names

US Brand Name

Descriptions

Amifostine is used to help prevent or lessen some of the side effects on the kidneys and salivary glands that are caused by cisplatin (a cancer medicine) or radiation therapy.

Amifostine is to be given only by or under the immediate supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in the product labeling, amifostine is used in certain patients with the following medical conditions:

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of amifostine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amifostine in the elderly. However, elderly patients are more likely to have age-related heart, liver, or kidney disease, which may require an adjustment of dose in patients receiving amifostine.

Pregnancy

Information about this amifostine-intravenous-route

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Congestive heart failure or

Heart attack, history of, or

Heart disease or

Heart rhythm problems or

Kidney disease or

Stroke, history of, or

Transient ischemic attacks (TIA or mini-stroke), history of—Use with caution. May cause side effects to become worse.

Dehydration or

Low blood pressure—Should not be used in patients with these conditions.

Proper Use

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.

This medicine is given before cisplatin therapy or radiation therapy. You may also receive other medicines to help prevent nausea and vomiting.

Drink plenty of fluids during the 24 hours before receiving amifostine.

Precautions

It is very important that your doctor check your progress at regular visits to allow for changes in your dose. Blood tests may be needed to check for any unwanted effects.

Low blood pressure (hypotension) may occur with this medicine. Check with your doctor right away if you have the following symptoms: blurred vision; confusion; severe dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly; sweating; or unusual tiredness or weakness.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have a rash on the lips or mouth; red skin lesions on the palms of the hands or soles of the feet; sores or ulcers on the skin; or fever or chills while you are receiving this medicine.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; trouble breathing; any swelling of your hands, face, or mouth; or chest pain after you receive this medicine.

This medicine may cause nausea and/or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these side effects.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Blurred vision

confusion

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

fainting or loss of consciousness

fast or irregular breathing

itching

nausea and vomiting

red, scaly, swollen, or peeling areas of the skin

skin rash

sweating

swelling of the eyes or eyelids

tightness in the chest

trouble with breathing

unusual tiredness or weakness

wheezing

Rare

Abdominal cramps

blistering, peeling, or loosening of the skin

burning or tingling sensation

chills

convulsions

cough

cracks in the skin

diarrhea

difficulty in breathing

fast, slow, or irregular heartbeat or pulse

fever

joint or muscle pain

loss of bladder control

loss of heat from the body

muscle cramps in the hands, arms, feet, legs, or face

muscle spasm or jerking of all extremities

no blood pressure or pulse

numbness and tingling around the mouth, fingertips, or feet

palpitations

red irritated eyes

red skin lesions, often with a purple center

shortness of breath

sore throat

sores, ulcers, or white spots in the mouth or on the lips

stopping of the heart

sudden loss of consciousness

tremor

unconsciousness

Incidence not known

Difficulty in swallowing

hives or welts

hoarseness

slow or irregular breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare

Feeling unusually warm or cold

flushing or redness of the face or neck

headache

hiccups

nervousness

pounding in the ears

sleepiness (severe)

sneezing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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